Generic Name: sofosbuvir velpatasvir voxilaprevir
Brand Name: Vosevi
Manufacturer: Gilead Sciences Canada, Inc.
Therapeutic Area: Hepatitis C, chronic
Indications: Hepatitis C, chronic
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: January 23, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Key Milestones2 | |
|---|---|
| Call for patient input posted | July 07, 2017 |
| Patient group input closed | August 28, 2017 |
| Clarification: Patient input submission received | |
| Patient input summary sent for review to patient input groups | August 30, 2017 |
| Patient group comments on input summary closed | September 07, 2017 |
| Clarification: - Patient input summary feedback received | |
| Submission received | July 28, 2017 |
| Submission accepted for review | August 14, 2017 |
| Review initiated | August 15, 2017 |
| Draft CDR review report(s) sent to applicant | October 30, 2017 |
| Comments from applicant on draft CDR review report(s) received | November 08, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | November 15, 2017 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | December 01, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | December 13, 2017 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | January 02, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | January 16, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | January 23, 2018 |
| CDEC Final Recommendation posted | January 25, 2018 |
| Final CDR review report(s) and patient input posted | February 07, 2018 |